Senate Supplement bill re SUPPLEMENTS, not good!

Discussion in 'Fibromyalgia Main Forum' started by victoria, Sep 23, 2010.

  1. victoria

    victoria New Member

    AAARGH.... again...

    "Pharmaceutical companies are once again interfering with your ability to access information about dietary supplements. The Senate is debating a bill that will enable the FDA to put vitamin supplement makers in jail for ten years if they cite findings from peer-reviewed published scientific studies on the label of their dietary supplements or their Web site. "

    There are more provisions than that, some of which I don't necessarily totally disagree with, but this bill goes too far. Especially when one takes into account the recent and never-ending scandals about pharma sponsored biased research about meds being used off-label.

    "If you want to protect your rights to supplements, please consider signing the petition below - it will be automatically sent to your senators. Due to the short session before Congress adjourns for the election, please do it today!

    You can do this in a few minutes at:

    If you’d like to read the legal details about this bill, log on to the Alliance for Natural Health Web site.

    thanks everybody...

  2. victoria

    victoria New Member

  3. victoria

    victoria New Member

    I agree with that.
    What I want is for a supplement to not be banned for years because of one contaminated lot as re what happened with L-Tryptophan. Yes there was serious contamination from 1 mfr. that resulted in illness and death. Yes it was found quickly and corrected. But we were barred (in US) from accessing it for many years totally. They do not do this with lettuce or spinach or whatever else that is in the food supply that sickens or kills people.

    Enough laws are already in place. The FDA is grossly undermanned and that is the problem. I don't think we need more rules/regulations, some (emphasis on 'some') are getting rather ridiculous. Given the FDAs actions in the past (which included burning books about stevia!), I fear them as much as I know equally how much they are needed.

    everybody has to make up their own minds as to how many new laws repeating old laws we need, and to watch out for the ones that may do more harm than good as often the HOW of implementation isn't realized til later. Sort of like the HC bill, as even Pelosi admittd (pass it and find out).

    OK that's my opinion... can't write more as I have a very uneven connection right now...

    I figure everybody can make up their own minds in any case, and write pro or con

  4. mbofov

    mbofov Active Member

    It does seem to be more than a matter of just quality control, if supplement manufacturers are barred from citing peer-reviewed research articles in support of their products.

    The ban on sales of all tryptophan was absurd. I cannot help but think it was linked to the sale of Prozac, which was just coming onto the market at that time, and tryptophan of course was a natural competitor.

  5. elliespad

    elliespad Member

    Ya READY FOR THIS? L-Tryptophan is used to treat Eosinophilia Myalgia Syndrome. L-Tryptophan was NOT the cause of the sickness or death. It was due to a contaminant from a change in manufacturing process. The only known treatment was found to be,,,,,,,,,,,,L-Tryptophan.

    The United States government issued patent number 5185157 on February 9, 1993, to use L-tryptophan to treat and cure EMS, and in fact, L-tryptophan may be the only effective treatment for EMS.

    You can read it here:

    Oh, and I signed the petition Victoria. Also signed for my husband, thanks. [This Message was Edited on 09/24/2010]
  6. Tizz

    Tizz New Member

    I can't believe you said that! The thing about L-Tryptophan has been bugging me for YEARS as a terrible example of a mis-handled contamination case that led to extreme over-reaction by the FDA.

    Thanks for mentioning it!
  7. Tizz

    Tizz New Member

    There have been many problems with imported products, including toxic toys, toxic candy, and a host of other things.

    The L-tryptophan was one of those. It wasn't the SUPPLEMENT that was bad, it was the contamination introduced by lax importation practices!!

    ...As for its effectiveness, that remains ambiguous but personally I find 5-HTP very effective, and so does my daughter. 5-htp is the supplement that many people turned to when L-tryptophan was removed from the market and they are chemically related.


    [This Message was Edited on 09/24/2010]
  8. victoria

    victoria New Member

    it did not take the officials all those years to figure out it was from one contaminated factory in Japan, they figured it out sooner than that. Give them some credit, even I do, LOL.

    & I don't necessarily believe it was taken off the market because of Prozac... all I do know is they stopped many from obtaining a very effective sleep aid, which prozac isn't, so I was never sure about why that was tied together.... 5 htp just doesn't do it for me.

    I know the FDA has acted very misguidedly at times, and at other times exemplary. It is also my opinion the agenda is for supplements to be rx'd by 'health providers' as in places like Germany, which will drive up costs... while there are pushes for all kinds of pharma meds to be sold otc as they come out of patent.

    The thing is there are already laws to cover these things. Passing more when those already in existence are not even being enforced is insane and leads to increased murkiness and, because of certain passages in that bill, even more laws that imo will do more harm than good. That really is my major point. Again, I have not seen lettuce or peppers pulled off all markets for years because of food poisoning and deaths.

    all of you who have signed....Thanks!

    PS: I am for truth in advertising... one reason to support consumerlabs...
    [This Message was Edited on 09/24/2010]
  9. victoria

    victoria New Member

    there are already laws in place. Otherwise the problem in the 90s with tryptophan and more recent things would not have been detected/tracked down. No system is 100% perfect, imo more laws won't make it so, just make the system more unwieldy.

    Tryptophan works extremely well for me for chronic insomnia, btw.

    So, I'll agree to disagree... can't stay on any longer tonight in any case...

  10. victoria

    victoria New Member

    and here are a few References

    1. Riemann, D., et al., The tryptophan depletion test: impact on sleep in primary insomnia - a pilot study. Psychiatry Res, 2002. 109(2): p. 129-35.

    2. Levitan, R.D., et al., Preliminary randomized double-blind placebo-controlled trial of tryptophan combined with fluoxetine to treat major depressive disorder: antidepressant and hypnotic effects. J Psychiatry Neurosci, 2000. 25(4): p. 337-46.

    3. Demisch, K., J. Bauer, and K. Georgi, Treatment of severe chronic insomnia with L-tryptophan and varying sleeping times. Pharmacopsychiatry, 1987. 20(6): p. 245-8.

    4. Spinweber, C.L., L-tryptophan administered to chronic sleep-onset insomniacs: late- appearing reduction of sleep latency. Psychopharmacology, 1986. 90(2): p. 151-5.

    5. Fitten, L.J., J. Profita, and T.G. Bidder, L-tryptophan as a hypnotic in special patients. J Am Geriatr Soc, 1985. 33(4): p. 294-7.

    6. Hartmann, E., J.G. Lindsley, and C. Spinweber, Chronic insomnia: effects of tryptophan, flurazepam, secobarbital, and placebo. Psychopharmacology, 1983. 80(2): p. 138-42.

    7. Schneider-Helmert, D., Interval therapy with L-tryptophan in severe chronic insomniacs. A predictive laboratory study. Int Pharmacopsychiatry, 1981. 16(3): p. 162-73.

    8. Hartmann, E. and R. Elion, The insomnia of 'sleeping in a strange place': effects of l-tryptophane. Psychopharmacology (Berl), 1977. 53(2): p. 131-3.

    9. Schneider-Helmert, D. and C.L. Spinweber, Evaluation of L-tryptophan for treatment of insomnia: a review. Psychopharmacology, 1986. 89(1): p. 1-7.

    10. Ferrero, F. and J. Zahnd, [Tryptophan in the treatment of insomnia in hospitalized psychiatric patients]. Encephale, 1987. 13(1): p. 35-7.

    I don't know of anything that works for all of us regarding sleep problems, do you?

  11. gapsych

    gapsych New Member

    Even if supplements were to work scientifically, if you buy them over the counter you have no idea what the supplement contains. I think this is the bottom line.

    There is something called GMP (Good Manufacturing Practices) which reputable places like ProHealth subscribe to.

    There are even some manufactures who want supplements to be regulated to give the companies more legitimacy.

    It took ten years to get Ephedra off the market.

    What if Big Pharma was not regulated and did not have to do rigorous trials to prove a medications effacacy.

    I edited the following by breaking up paragraphs to make for easier reading. Bold print is mine.



    "The enactment into law of the Dietary Supplement Health and Education Act (DSHEA) in the United States (US) in 1994 is an example of a piece of pro-health-freedom legislation.

    DSHEA defines supplements as foods, and puts the onus on the United States Food and Drug Administration (FDA) to prove that a supplement poses significant or unreasonable risk of harm rather than on the manufacturer to prove the supplement’s safety.

    The act was passed by Congress after extensive lobbying by the manufacturers of dietary supplements and received strong support from non-medically-oriented politicians such as Senator Tom Harkin and Senator Orrin Hatch, whose state of Utah is a hub for herbal manufacturers.

    The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements and restricted the ability of the FDA to exert authority over supplements so long as manufacturers made no claims about their products treating, preventing or curing diseases.

    Accordign to Consumer Reports, "The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications" and it became the FDA's responsibility to prove that a supplement wasn't safe.

    While pharmaceutical manufacturers must demonstrate their products are effective as well as being safe, supplement manufacturers are NOT REQUIRED TO DEMONSTRATE EFFICACY.

    "The FDA has only ever found one dietary supplement to be unsafe, the weight loss/energy supplement ephedra.

    Discussing the legislation,Time referred to the DSHEA as "ill-conceived and reprehensible", that "gives the industry virtually free reign [sic] to market products defined as dietary supplements, while severely limiting the FDA's ability to regulate them".

    The DSHEA was heavily lobbied for by the supplement industry, and was criticized for exposing the public to worthless compounds that bilked consumers out of money to no benefit.

    Because of the requirements put into place by the DSHEA, the FDA must demonstrate that individual supplements are unsafe using their adverse events reporting system, WHICH IS ESTIMATED CAPTURES ONLY 1% OF ALL ADVERSE EVENTS linked to supplements.

    The FDA has also lacked the funding to undertake the rigorous tests to meet the standards for a supplement to be considered "hazardous" and thus removed from the market; in the one situation where this standard was reached (ephedra), the agency faced significant opposition."

    Jaroff, L (2004-02-10). "Beyond Ephedra". Time.,8816,589533,00.html. Retrieved 2010-07-28.

    Dangerous supplements: still at large". Consumer Reports. 2004-05-01. Retrieved 2010-07-28.
  12. victoria

    victoria New Member

    Many studies have been done without the active part of a herb in order to say they do not work (reminds me of how some XMRV studies were done without doing the exact procedures that the WPI used); Consumer Reports article wasn't well done overall... I don't have the time to look these up. I agree of course mfrs should want good quality control,r just don't think we need more laws, nor restriction of freedom of speech, which is what in part this bill is trying to do.

    Thanks everybody for keeping this bumped.

    all the best
  13. gapsych

    gapsych New Member

    This "do gooder" only wants the people who are taking advantage of people to suffer the consequences.

    The only law I am aware of and PH follows this is the GMP (Good Manufacturing Practices).

    So at this time supplemental companies can:

    1. Sell supplements without any oversight.

    2. Not have to prove something is effective.

    3. The burden of proof is on the underfunded FDC and not the manufacturers.

    4. Reporting adverse events is on the honor system.

    5. What the label says is in the bottle is not guaranteed.

    What I don't understand is people who often complain about the side effects of pharma. medications and yet don't worry about the side effects of supplements. As stated in the above post it is estimated that only 11% of adverse reactions are caught. Consumers may not realize they are getting side effects from supplements or they are "herxing".

    If you have a deficiency then you need the supplements. I get mine by prescription and it is a lot cheaper than buying it at a health food store.

    There are some supplements that may have medicinal qualities but most likely not as effective as pharma. drugs.

    Not trying to change minds but want to present the other side for those who may not be aware that supplements are not regulated. Something like 51% of consumers think supplements are regulated.

    I will come back and cite the references.

    Natural does not mean better.


  14. quanked

    quanked Member

    This is from the body of a letter that opposes the new Food Safety Accountability Act of 2010--

    I was shocked to read the provisions of S. 3767, the new Food Safety
    Accountability Act of 2010. It contains draconian penalties for even minor infractions--so much so that I wonder if Senators Leahy, Klobuchar, and Franken have actually read the fine print of the bill.

    This bill gives the US Food and Drug Administration vastly expanded
    powers, and increases criminal penalties to ten years' imprisonment for
    any person who knowingly introduces or delivers for introduction into
    interstate commerce any food that is adulterated or misbranded, or for any person to adulterate or misbrand any food in interstate commerce.

    The problem, of course, is that the terms "misbranded"and "adulterated" are so broadly defined that they include even minor record-keeping violations, as well as selling a product whose manufacturer has cited peer-reviewed science about the product's benefits.

    As I'm sure you're aware, the FDA has a long history of targeting natural
    health product companies under false pretenses. This is what happened to a group of cherry producers that cited Harvard research about the benefits of cherries on their website. The FDA forced them to sign a consent decree so burdensome that it almost put them out of business. With the bigger threat of increased criminal penalties, the FDA would practically have free rein.

    As one of your constituents, I wanted you to know that I take dietary
    supplements regularly, and value their help in keeping my family healthy. This bill is a misguided attempt to protect our food supply or ensure the safety of supplements--instead, it practically ensures that natural product makers will be threatened, silenced, and penalized.

    This bill won't even necessarily hold accountable a company which tainted a product, even on purpose, if the adulteration occurred before the product was sold by a distributor!

    Please, Senator--this is just a bad bill. I strongly urge you to fight and
    defeat it.--
  15. victoria

    victoria New Member

    We don't know much about much and laws don't make much of a difference.
    Fallout occurs later with everything.

    I just read a recently released study that claims 85% of new drugs are 'lemons' -
    makes for quite interesting reading - again taking recent problems with drugs into consideration....

    I believe ConsumerLab is on par (or getting there) with Underwriters Lab/UL - an independent testing lab since 1894.

  16. victoria

    victoria New Member

    I'd really like to know who put the part in about supplements tho....